EP0551700B2 - Film coatings and film coating compositions based on cellulosic polymers and lactose - Google Patents
Film coatings and film coating compositions based on cellulosic polymers and lactose Download PDFInfo
- Publication number
- EP0551700B2 EP0551700B2 EP92300406A EP92300406A EP0551700B2 EP 0551700 B2 EP0551700 B2 EP 0551700B2 EP 92300406 A EP92300406 A EP 92300406A EP 92300406 A EP92300406 A EP 92300406A EP 0551700 B2 EP0551700 B2 EP 0551700B2
- Authority
- EP
- European Patent Office
- Prior art keywords
- weight
- composition
- dry film
- hpmc
- film coating
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 239000000203 mixture Substances 0.000 title claims description 62
- 239000007888 film coating Substances 0.000 title claims description 53
- 238000009501 film coating Methods 0.000 title claims description 53
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 title claims description 37
- 239000008101 lactose Substances 0.000 title claims description 37
- 229920000642 polymer Polymers 0.000 title claims description 13
- 238000000576 coating method Methods 0.000 claims description 54
- 239000011248 coating agent Substances 0.000 claims description 53
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 52
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 52
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 52
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 52
- 239000000725 suspension Substances 0.000 claims description 48
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 36
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 35
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 35
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 35
- 239000004615 ingredient Substances 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 20
- 239000000049 pigment Substances 0.000 claims description 19
- 239000004014 plasticizer Substances 0.000 claims description 18
- 239000000758 substrate Substances 0.000 claims description 17
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 15
- 235000009508 confectionery Nutrition 0.000 claims description 15
- 235000013305 food Nutrition 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 11
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N iron oxide Inorganic materials [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 8
- 238000005507 spraying Methods 0.000 claims description 7
- 235000013980 iron oxide Nutrition 0.000 claims description 6
- 239000004408 titanium dioxide Substances 0.000 claims description 5
- VBMVTYDPPZVILR-UHFFFAOYSA-N iron(2+);oxygen(2-) Chemical class [O-2].[Fe+2] VBMVTYDPPZVILR-UHFFFAOYSA-N 0.000 claims description 4
- 239000003814 drug Substances 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 2
- 239000007921 spray Substances 0.000 claims description 2
- 229940113115 polyethylene glycol 200 Drugs 0.000 claims 3
- 230000001419 dependent effect Effects 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 229920003091 Methocel™ Polymers 0.000 description 17
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 15
- KHLVKKOJDHCJMG-QDBORUFSSA-L indigo carmine Chemical compound [Na+].[Na+].N/1C2=CC=C(S([O-])(=O)=O)C=C2C(=O)C\1=C1/NC2=CC=C(S(=O)(=O)[O-])C=C2C1=O KHLVKKOJDHCJMG-QDBORUFSSA-L 0.000 description 14
- 229960003988 indigo carmine Drugs 0.000 description 14
- 235000012738 indigotine Nutrition 0.000 description 14
- 239000004179 indigotine Substances 0.000 description 14
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 11
- 239000008199 coating composition Substances 0.000 description 5
- 150000001720 carbohydrates Chemical class 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 239000006185 dispersion Substances 0.000 description 3
- 239000008240 homogeneous mixture Substances 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 2
- 229920000604 Polyethylene Glycol 200 Polymers 0.000 description 2
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 description 2
- 229920002594 Polyethylene Glycol 8000 Polymers 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 229960001138 acetylsalicylic acid Drugs 0.000 description 2
- 235000015496 breakfast cereal Nutrition 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 229920003086 cellulose ether Polymers 0.000 description 2
- 229940112822 chewing gum Drugs 0.000 description 2
- 235000015218 chewing gum Nutrition 0.000 description 2
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 150000003722 vitamin derivatives Chemical class 0.000 description 2
- KPIQXPLWZCDIHI-ISLYRVAYSA-N 5-hydroxy-1-(4-sulfophenyl)-4-[(e)-(4-sulfophenyl)diazenyl]-1h-pyrazole-3-carboxylic acid Chemical compound OC(=O)C1=NN(C=2C=CC(=CC=2)S(O)(=O)=O)C(O)=C1\N=N\C1=CC=C(S(O)(=O)=O)C=C1 KPIQXPLWZCDIHI-ISLYRVAYSA-N 0.000 description 1
- 229920002538 Polyethylene Glycol 20000 Polymers 0.000 description 1
- 241000607479 Yersinia pestis Species 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000009500 colour coating Methods 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 238000010410 dusting Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 239000003517 fume Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000003595 mist Substances 0.000 description 1
- 239000012860 organic pigment Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000009490 roller compaction Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 235000012756 tartrazine Nutrition 0.000 description 1
- 239000004149 tartrazine Substances 0.000 description 1
- 229960000943 tartrazine Drugs 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000003245 working effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01C—PLANTING; SOWING; FERTILISING
- A01C1/00—Apparatus, or methods of use thereof, for testing or treating seed, roots, or the like, prior to sowing or planting
- A01C1/06—Coating or dressing seed
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
- A23P20/10—Coating with edible coatings, e.g. with oils or fats
- A23P20/105—Coating with compositions containing vegetable or microbial fermentation gums, e.g. cellulose or derivatives; Coating with edible polymers, e.g. polyvinyalcohol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09G—POLISHING COMPOSITIONS; SKI WAXES
- C09G1/00—Polishing compositions
- C09G1/06—Other polishing compositions
- C09G1/08—Other polishing compositions based on wax
Definitions
- the present invention relates to the field of aqueous film coating of pharmaceutical, food, confectionery, forms, and agricultural products, and is specifically concerned with providing coatings from a combination of a cellulosic polymer and lactose for coating such things as pharmaceutical tablets, pieces of candy, cereals, and agricultural seeds.
- Film coating is a process of depositing a thin layer of material onto a substrate.
- Two goals of film coating substrates such as pharmaceutical tablets and the like are (1) to provide a functional protective barrier covering the outer surface of the substrate, and (2) to provide a pleasing appearance.
- the process of film coating pharmaceutical, food, confectionery, and agricultural pieces usually involves rolling the pieces in a pan, or suspending the pieces on a cushion of air, and continuously spraying a fine mist of atomized droplets of a coating suspension onto the pieces, the droplets coalescing on the surface of the pieces to form a film coating.
- Coating suspensions having an organic solvent are undesirable since these solvents are often flammable, often toxic, and hazardous to the health of film coating workings. Further, reclaiming organic solvent fumes, which are given off during spraying, from exhaust air ducting systems is expensive and often required by law.
- Water-based coating suspensions are desirable to avoid the drawbacks of organic solvent-based coating suspensions.
- a major problem with aqueous coating suspensions is poor adhesion of the film to the substrate.
- JP 51-123815 discloses an aqueous coating composition containing water soluble cellulose ether and saccharide, with other non-aqueous components such as plasticisers or pigments, at 1-200 parts by weight saccharide per 100 parts by weight of the cellulose ether. Lactose is given as a suitable saccharide.
- JP 49-133515 discloses an aqueous coating composition containing HPMC and a saccharide at a ratio by weight of 4:1 to 1:1.
- a dry film coating composition for use in pharmaceuticals, food confectionery forms, agricultural seeds, and the like comprises a dry mixture of a cellulosic polymer and lactose, wherein the cellulosic polymer is hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), in an amount from 11% to 30% by weight of the composition, preferably from 20% to 30% by weight.
- the composition may include a plasticizer and/or a pigment.
- a method of coating substrates such as pharmaceutical tablets, food and confectionery forms, agricultural seeds, and the like, comprises mixing a cellulosic polymer and lactose into water to form an aqueous coating suspension, wherein the cellulosic polymer is hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), in an amount from 11% to 30% by weight of the non-water ingredients, preferably from 20% to 30% by weight, spraying the coating suspension onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.
- HPMC hydroxypropyl methylcellulose
- HPC hydroxypropyl cellulose
- the invention also includes the coated substrates, such as coated pharmaceutical tablets, and methods of making the dry film coating composition and of making a coating suspension.
- plasticizer examples include polyethylene glycol having a molecular weight of 200 to 20,000, propylene glycol, or glycerol.
- any of the pigments heretofore used in making coating dispersions for coating tablets, food, confectionery forms, agricultural seeds, and the like may be used.
- Examples are FD&C and D&C lakes, titanium dioxide, iron oxides or natural pigments.
- the quantity of the cellulosic polymer is within a range of 11 % to 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of 20% to 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- the quantity of the lactose is within a range of about 11 % to about 56% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 25% to 45% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- the quantity of the plasticizer is within a range of 0% to about 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 5% to 20% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- the quantity of the pigment is within a range of 0% to about 55% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 15% to 40% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- a preferred formula for the present inventive dry film coating composition is: COMPONENT % w/w CELLULOSIC POLYMER 26.80 LACTOSE 40.20 PLASTICIZER 8.00 PIGMENT 25.00
- the following examples of the invention all disclose formulations which may be mixed into water to form an aqueous coating suspension effective to coat pharmaceutical tablets, food and confectionery pieces, and agricultural seeds. Seeds are advantageously coated to meet various needs, such as color coating for identification purposes, adhesion of various additives, ( e.g. , pest control agents and inocula), prevention of handling damage, and facilitating the use of mechanical planting equipment
- the coated forms include medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds.
- hydroxypropyl methylcellulose (Methocel E15 made by Dow Chemical Company)
- 100.50 grams of lactose, 60.00 grams of titanium dioxide, and 2.50 grams of Indigo carmine aluminum lake 14% are loaded into a dry powder blender such as a P.K. blender and mixed Vigorously for 25 minutes to form an homogenous mixture.
- 20.00 grams of a plasticizer, polyethylene glycol 4000, (PEG 4000 made by Union Carbide) is added to the homogenous mixture and gently blended into it
- the homogenous mixture containing the plasticizer is granulated using a planetary mixer, such as a Hobart planetary mixer.
- a planetary mixer such as a Hobart planetary mixer.
- sufficient water is slowly added until the composition forms slightly adherent granules.
- These granules are then passed through a 1-2 mm screen and then dried in a 30°C oven until the moisture content is below 5%.
- the composition is then sieved again through a 1-2mm screen and is then ready for use in a non-dusting, granular form.
- the powder may be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example.
- Example 2 shows different formulations of the dry film coating composition of the invention, further illustrate the invention.
- a dry film coating composition is made using the procedure of Example 1.
- Methocel E15 and Methocel E50 are hydroxypropyl methylcellulose (HPMC) made by Dow Chemical Company.
- PEG 200, PEG 400, PEG 4000, PEG 8000, and PEG 20000 are polyethylene glycol made by Union Carbide.
- Klucel EF is hydroxypropyl cellulose made by Hercules Co.
- a dry film coating composition having the following formula is made as in example 1, except that no plasticizer is blended into the composition: COMPONENT % w/w grams HPMC (Methocel E15) 29.13 72.82 LACTOSE 43.70 109.25 TiO2 26.08 65.20 INDIGO CARMINE ALUMINUM LAKE 14% 1.09 2.73 100.00 250.00
- each of the dry film coating compositions of Examples 1-17 is constituted in water to form a coating suspension.
- 170 grams of the dry film coating composition is dispersed into 830 grams of purified water.
- this is accomplished by placing the 830 grams of purified water into a mixing vessel having the diameter that is about equal to the depth of the final suspension.
- a low shear mixer is lowered into the water and turned on.
- the mixing head of the mixer is about one third the diameter of the mixing vessel and creates a vortex from the edge of the vessel down to just above the mixing head.
- the 170 grams of the dry film coating composition is then added to the vortex at a rate where there is no excessive build-up of the dry film coating composition.
- the speed and depth of the mixing head is adjusted to avoid air being drawn into the suspension which would result in foaming.
- the suspension is stirred for 45 minutes and is then ready for spraying.
- inventive coating suspensions are then sprayed onto medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds, and allowed to dry.
- the film coatings so produced have an excellent appearance and adhere extremely well to the substrates.
- the inventive film coating suspension is formed by blending together all the dry ingredients of the coating formula, and then dispersing the mixture of the dry ingredients into water.
- the film coating suspension may be prepared by stirring the ingredients of the coating formulation one by one into water to form a coating suspension.
- inventive coating suspension may be spray-granulated to form a dry edible film coating composition that may be remixed into water when desired to form a coating suspension.
- lactose in the coating composition dramatically and unexpectedly improves adhesion of the film coating onto substrates such as pharmaceuticals, food, confectionery forms, agricultural seeds, and the like.
- the dry film coating composition of the invention when constituted in water has a viscosity lower than that of a conventional polymer coating system having the same total solids.
- a coating dispersion may be produced under the invention which has a higher solids loading, and consequently a lower solvent content Accordingly, since the film coating suspensions of the invention may be sprayed at a higher solids level, spraying times are lower than the spraying times for conventional systems, which results in lower processing time cost.
- lactose in the inventive formulation improves the light stability of organic pigments and natural colors commonly used in film coatings.
- lactose in the formulation has the effect of reducing the moisture vapor permeability of the film.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Soil Sciences (AREA)
- Environmental Sciences (AREA)
- Biotechnology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Medicinal Preparation (AREA)
- Pretreatment Of Seeds And Plants (AREA)
- Cosmetics (AREA)
- Paints Or Removers (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Description
- The present invention relates to the field of aqueous film coating of pharmaceutical, food, confectionery, forms, and agricultural products, and is specifically concerned with providing coatings from a combination of a cellulosic polymer and lactose for coating such things as pharmaceutical tablets, pieces of candy, cereals, and agricultural seeds.
- Film coating is a process of depositing a thin layer of material onto a substrate. Two goals of film coating substrates such as pharmaceutical tablets and the like are (1) to provide a functional protective barrier covering the outer surface of the substrate, and (2) to provide a pleasing appearance.
- The process of film coating pharmaceutical, food, confectionery, and agricultural pieces usually involves rolling the pieces in a pan, or suspending the pieces on a cushion of air, and continuously spraying a fine mist of atomized droplets of a coating suspension onto the pieces, the droplets coalescing on the surface of the pieces to form a film coating.
- Coating suspensions having an organic solvent are undesirable since these solvents are often flammable, often toxic, and hazardous to the health of film coating workings. Further, reclaiming organic solvent fumes, which are given off during spraying, from exhaust air ducting systems is expensive and often required by law.
- Water-based coating suspensions are desirable to avoid the drawbacks of organic solvent-based coating suspensions. However, a major problem with aqueous coating suspensions is poor adhesion of the film to the substrate.
- JP 51-123815 discloses an aqueous coating composition containing water soluble cellulose ether and saccharide, with other non-aqueous components such as plasticisers or pigments, at 1-200 parts by weight saccharide per 100 parts by weight of the cellulose ether. Lactose is given as a suitable saccharide.
- JP 49-133515 discloses an aqueous coating composition containing HPMC and a saccharide at a ratio by weight of 4:1 to 1:1.
- A dry film coating composition for use in pharmaceuticals, food confectionery forms, agricultural seeds, and the like comprises a dry mixture of a cellulosic polymer and lactose, wherein the cellulosic polymer is hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), in an amount from 11% to 30% by weight of the composition, preferably from 20% to 30% by weight. Optionally, the composition may include a plasticizer and/or a pigment.
- A method of coating substrates such as pharmaceutical tablets, food and confectionery forms, agricultural seeds, and the like, comprises mixing a cellulosic polymer and lactose into water to form an aqueous coating suspension, wherein the cellulosic polymer is hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), in an amount from 11% to 30% by weight of the non-water ingredients, preferably from 20% to 30% by weight, spraying the coating suspension onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.
- The invention also includes the coated substrates, such as coated pharmaceutical tablets, and methods of making the dry film coating composition and of making a coating suspension.
- Exemplary of the plasticizer are polyethylene glycol having a molecular weight of 200 to 20,000, propylene glycol, or glycerol.
- Any of the pigments heretofore used in making coating dispersions for coating tablets, food, confectionery forms, agricultural seeds, and the like may be used. Examples are FD&C and D&C lakes, titanium dioxide, iron oxides or natural pigments.
- The quantity of the cellulosic polymer is within a range of 11 % to 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of 20% to 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- The quantity of the lactose is within a range of about 11 % to about 56% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 25% to 45% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- The quantity of the plasticizer is within a range of 0% to about 30% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 5% to 20% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- The quantity of the pigment is within a range of 0% to about 55% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension. A range of about 15% to 40% by weight of the dry film coating composition and of the non-water ingredients of the aqueous coating suspension is preferred.
- A preferred formula for the present inventive dry film coating composition is:
COMPONENT % w/w CELLULOSIC POLYMER 26.80 LACTOSE 40.20 PLASTICIZER 8.00 PIGMENT 25.00 - The following examples of the invention all disclose formulations which may be mixed into water to form an aqueous coating suspension effective to coat pharmaceutical tablets, food and confectionery pieces, and agricultural seeds. Seeds are advantageously coated to meet various needs, such as color coating for identification purposes, adhesion of various additives, (e.g., pest control agents and inocula), prevention of handling damage, and facilitating the use of mechanical planting equipment The coated forms include medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds.
- The following examples illustrate the invention. All units and percentages used herein are by weight.
- 67.00 grams of hydroxypropyl methylcellulose (Methocel E15 made by Dow Chemical Company), 100.50 grams of lactose, 60.00 grams of titanium dioxide, and 2.50 grams of Indigo carmine aluminum lake 14% are loaded into a dry powder blender such as a P.K. blender and mixed Vigorously for 25 minutes to form an homogenous mixture. Then, 20.00 grams of a plasticizer, polyethylene glycol 4000, (PEG 4000 made by Union Carbide), is added to the homogenous mixture and gently blended into it
- Optionally, the homogenous mixture containing the plasticizer is granulated using a planetary mixer, such as a Hobart planetary mixer. After the dry film coating composition is loaded into the mixer and the mixer is switched on, sufficient water is slowly added until the composition forms slightly adherent granules. These granules are then passed through a 1-2 mm screen and then dried in a 30°C oven until the moisture content is below 5%. The composition is then sieved again through a 1-2mm screen and is then ready for use in a non-dusting, granular form. If not optionally granulated in a planetary mixer, the powder may be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example.
- Other methods of granulation which may be used are spray granulation and roller compaction.
- The following examples 2 to 17, which show different formulations of the dry film coating composition of the invention, further illustrate the invention. In each example 2 to 17; a dry film coating composition is made using the procedure of Example 1. Methocel E15 and Methocel E50 are hydroxypropyl methylcellulose (HPMC) made by Dow Chemical Company. PEG 200, PEG 400, PEG 4000, PEG 8000, and PEG 20000 are polyethylene glycol made by Union Carbide. Klucel EF is hydroxypropyl cellulose made by Hercules Co.
-
COMPONENT % w/w grams HPMC (Methocel E15) 20.39 50.98 LACTOSE 30.58 76.44 PEG 4000 30.00 75.00 Ti02 18.27 45.68 INDIGO CARMINE ALUMINUM LAKE 14% 0.76 1.90 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 16.00 40.00 LACTOSE 24.00 60.00 PEG 4000 14.55 36.38 Ti02 43.64 109.10 INDIGO CARMINE ALUMINUM LAKE 14% 1.81 4.52 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 11.17 27.93 LACTOSE 55.83 139.57 PEG 4000 8.00 20.00 Ti02 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 15.66 39.15 LACTOSE 24.00 60.00 PEG 4000 5.34 13.35 TiO2 52.80 132.00 INDIGO CARMINE ALUMINUM LAKE 14% 2.20 5.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 4000 8.00 20.00 IRON OXIDE YELLOW 25.00 62.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 4000. 8.00 20.00 TiO2 24.00 60.00 IRON OXIDE YELLOW 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 4000 8.00 20.00 TiO2 1.00 2.50 INDIGO CARMINE ALUMINUM LAKE 14% 24.00 60.00 100.00 250.00 -
COMPONENT % w/w grams HPMC(Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 400 8.00 20.00 TiO2 24.00 60.60 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PROPYLENE GLYCOL 8.00 20.00 TiO2 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC(Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 GLYCEROL 8.00 20.00 TiO2 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPC (Klucel EF) 26.80 67.00 LACTOSE 40.20 100.50 PEG4000 8.00 20.00 Ti02 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E50) 20.83 52.07 LACTOSE 41.67 104.17 PEG 4000 6.25 15.63 TiO2. 30.00 75.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.25 3.13 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 8000 8.00 20.00 TiO2 24.00 60.00 TARTRAZINE ALUMINUM LAKE 25% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Metnocel E15) 26.80, 67.00 LACTOSE 40.20 100.50 PEG 20,000 8.00 20.00 TiO2 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 -
COMPONENT % w/w grams HPMC (Methocel E15) 26.80 67.00 LACTOSE 40.20 100.50 PEG 200 8.00 20.00 TiO2 24.00 60.00 INDIGO CARMINE ALUMINUM LAKE 14% 1.00 2.50 100.00 250.00 - A dry film coating composition having the following formula is made as in example 1, except that no plasticizer is blended into the composition:
COMPONENT % w/w grams HPMC (Methocel E15) 29.13 72.82 LACTOSE 43.70 109.25 TiO2 26.08 65.20 INDIGO CARMINE ALUMINUM LAKE 14% 1.09 2.73 100.00 250.00 - Each of the dry film coating compositions of Examples 1-17 is constituted in water to form a coating suspension. In each case, 170 grams of the dry film coating composition is dispersed into 830 grams of purified water. Preferably, this is accomplished by placing the 830 grams of purified water into a mixing vessel having the diameter that is about equal to the depth of the final suspension. Then, a low shear mixer is lowered into the water and turned on. Preferably, the mixing head of the mixer is about one third the diameter of the mixing vessel and creates a vortex from the edge of the vessel down to just above the mixing head. The 170 grams of the dry film coating composition is then added to the vortex at a rate where there is no excessive build-up of the dry film coating composition. The speed and depth of the mixing head is adjusted to avoid air being drawn into the suspension which would result in foaming. The suspension is stirred for 45 minutes and is then ready for spraying.
- The inventive coating suspensions are then sprayed onto medicinal tablets, vitamin tablets, aspirin tablets, capsules, chewing gum balls, candy pieces, breakfast cereals, and agricultural seeds, and allowed to dry. The film coatings so produced have an excellent appearance and adhere extremely well to the substrates.
- Preferably, the inventive film coating suspension is formed by blending together all the dry ingredients of the coating formula, and then dispersing the mixture of the dry ingredients into water. However, the film coating suspension may be prepared by stirring the ingredients of the coating formulation one by one into water to form a coating suspension.
- Further, the inventive coating suspension may be spray-granulated to form a dry edible film coating composition that may be remixed into water when desired to form a coating suspension.
- The inclusion of lactose in the coating composition dramatically and unexpectedly improves adhesion of the film coating onto substrates such as pharmaceuticals, food, confectionery forms, agricultural seeds, and the like.
- The dry film coating composition of the invention when constituted in water has a viscosity lower than that of a conventional polymer coating system having the same total solids. For an equivalent final dispersion viscosity as a conventional polymer coating system, a coating dispersion may be produced under the invention which has a higher solids loading, and consequently a lower solvent content Accordingly, since the film coating suspensions of the invention may be sprayed at a higher solids level, spraying times are lower than the spraying times for conventional systems, which results in lower processing time cost.
- Most cellulosic polymers show some degree of tack as they dry on the substrate surface. This tack is reduced with the inclusion of lactose in the inventive formula, thus further facilitating faster processing times, and thereby lowering costs.
- The inclusion of lactose in the inventive formulation improves the light stability of organic pigments and natural colors commonly used in film coatings.
- The inclusion of lactose in the formulation has the effect of reducing the moisture vapor permeability of the film.
Claims (34)
- A dry film coating composition for use in pharmaceuticals, food, confectionery forms, agricultural seeds, and the like, comprising:a cellulosic polymer and lactose, wherein the cellulosic polymer is hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), in an amount from 11% to 30% by weight of the composition.
- A dry film composition according to claim 1, comprising hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) in an amount from 20% to 30% by weight of the composition.
- A dry film composition according to claim 1 or 2, further comprising a plasticizer.
- A dry film coating composition according to claim 3, in which the plasticizer is polyethylene glycol 200 to 20,000, propylene glycol, or glycerol.
- A dry film coating composition according to claim 3 or 4, in which the plasticizer content is up to 30% by weight of the composition.
- A dry film coating composition according to any preceding claim, further comprising a pigment.
- A dry film coating composition according to claim 6 in which the pigment is at least one of FD&C lakes, D&C lakes, titanium dioxide, iron oxides, or natural pigments.
- A dry film coating composition according to claim 6 or 7, in which the pigment content is up to 55% by weight of the composition.
- A dry film coating composition according to any preceding claim, in which the lactose content is from 11% to 20% by weight of the composition.
- A method of coating substrates such as pharmaceutical tablets, food and confectionery forms, agricultural seeds, comprising:mixing hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) and lactose into waterto form an aqueous coating suspension, the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forming from 11% to 30% by weight of the non-water ingredients;spraying the coating suspension onto the substrates to form a film coating on the substrates; anddrying the film coating on said substrates.
- The method according to claim 10, wherein the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forms from 20% to 30% by weight of the non-water ingredients.
- A method of making a dry film coating composition for use in coating pharmaceutical tablets, food, confectionery forms, agricultural seeds, comprising mixing hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) and lactose together to form a dry film coating composition, the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forming from 11% to 30% by weight of the composition.
- The method according to claim 12, wherein the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forms from 20% to 30% by weight of the composition.
- A method according to claim 12 or 13, further comprising granulating the dry film coating: composition.
- A method of making a dry film coating composition for use in coating pharmaceutical tablets, food and confectionery forms, agricultural seeds, comprising mixing hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) and lactose into water to form an aqueous coating suspension, the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HFC) forming from 11% to 30% by weight of the composition, and spray granulating the aqueous coating suspension to form a dry film coating composition.
- The method according to claim 15, wherein the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forms from 20% to 30% by weight of the composition.
- A method according to claims 10, 11, 15 or 16, further comprising adding a plasticizer to the aqueous coating suspension.
- A method according to claims 12, 7.3. or 14 further comprising mixing-a plasticizer with the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) and the lactose until blended to form the dry film coating composition.
- A method according to claims 17 or 18, in which the plasticizer is polyethylene glycol 200 to 20,000, propylene glycol, or glycerol.
- A method according to claim 17, 18, or 19, in which the plasticizer content is up to 30% by weight of the non-water ingredients of the composition.
- A method according to claims 10, 11, 15, 16 and 17 or to claim 19 or 20 when dependent on any of claims 10, 11, 15, 16, and 17, further comprising dispersing a pigment into the coating suspension.
- A method according to claims 12, 13, 14, or 18 or to claim 19 or 20 when dependent on claim 12, 13, 14, or 18, further comprising adding a pigment to the mixture and mixing until the combined mix is blended to form the dry film coating composition.
- A method according to any of claims 21 or 22 in which the pigment is at least one of the FD&C lakes, D&C lakes, titanium dioxide, iron oxides, or natural pigments.
- A method according to claims 21, 22 or 23 in which the pigment content is up to 55% by weight of the non-water ingredients of the coating suspension.
- A method according to.any of claims 10 to 24, in which the lactose content is from 11% to 55% by weight of the non-water ingredients of the coating suspension.
- An aqueous coating suspension for coating substrates such as pharmaceutical tablets, food and confectionery forms, agricultural seeds, comprising a mixture of hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), lactose, and water, the hydroxypropyl methylcellulose (HFMC), or hydroxypropyl cellulose (HPC) forming from 11% to 30% by weight of the non-water ingredients.
- An aqueous coating suspension according to claim 26, in which the hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC) forms from 20% to 30% by weight of the non-water ingredients.
- An aqueous coating suspension according to claim 26 or 27, further comprising a plasticizer.
- An aqueous coating suspension according to claim 28, in which the plasticizer is polyethylene glycol 200 to 20,000, propylene glycol, or glycerol.
- An aqueous coating suspension according to claims 28 or 29, in which the plasticizer content is up to 30% by weight of the non-water ingredients of the coating suspension.
- An aqueous coating suspension according to any of claims 26 to 30, further comprising a pigment.
- An aqueous coating suspension according to claim 31, in which the pigment is at least one of FD&D lakes, D&C lakes, titanium dioxide, iron oxides, or natural pigments.
- An aqueous coating suspension according to claims 31 or 32, in which the pigment content is up to 55% by weight of the non-water ingredients of the coating suspension.
- An aqueous coating suspension according to any of claims 26 to 33, in which the lactose content is 11 to 56% by weight of the non-water ingredients of the coating suspension.
Priority Applications (14)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9111514A GB2256648B (en) | 1991-05-29 | 1991-05-29 | Wax polish composition |
DE69219303T DE69219303T3 (en) | 1991-05-29 | 1992-01-17 | Film coatings and coating compositions based on cellulosic polymers and lactose |
EP92300406A EP0551700B2 (en) | 1991-05-29 | 1992-01-17 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
ES92300406T ES2100279T5 (en) | 1991-05-29 | 1992-01-17 | COATINGS IN THE FORM OF A FILM AND COMPOSITIONS FOR COVERING IN THE FORM OF A FILM BASED ON CELLULOSICAL AND LACTOSE POLYMERS. |
US07/889,775 US5389129A (en) | 1991-05-29 | 1992-05-28 | Wax polish composition |
ZA93225A ZA93225B (en) | 1991-05-29 | 1993-01-13 | Film coatings and film coating compositions based on cellulosic polymers and lactose. |
JP51042193A JP3703481B2 (en) | 1992-01-17 | 1993-01-15 | Film coatings and coating compositions based on cellulose polymers and lactose |
AU35839/93A AU674840B2 (en) | 1992-01-17 | 1993-01-15 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
IE1993/0025A IE84149B1 (en) | 1993-01-15 | Film coatings and film coating compositions based on cellulosic polymers and lactose | |
PCT/US1993/000383 WO1993014158A1 (en) | 1992-01-17 | 1993-01-15 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
KR1019940702463A KR940703886A (en) | 1992-01-17 | 1993-01-15 | Film Coatings and Film Coating Compositions Based on Cellulosic Polymers and Lactose |
CN93100417A CN1065263C (en) | 1991-05-29 | 1993-01-16 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
US08/400,134 US5630871A (en) | 1991-01-17 | 1995-03-06 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
US08/858,787 US5743947A (en) | 1991-01-17 | 1997-05-19 | Film coatings and film coating compositions based on cellulosic polymers and lacttose |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9111514A GB2256648B (en) | 1991-05-29 | 1991-05-29 | Wax polish composition |
EP92300406A EP0551700B2 (en) | 1991-05-29 | 1992-01-17 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
Publications (3)
Publication Number | Publication Date |
---|---|
EP0551700A1 EP0551700A1 (en) | 1993-07-21 |
EP0551700B1 EP0551700B1 (en) | 1997-04-23 |
EP0551700B2 true EP0551700B2 (en) | 2007-04-18 |
Family
ID=40303617
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP92300406A Expired - Lifetime EP0551700B2 (en) | 1991-01-17 | 1992-01-17 | Film coatings and film coating compositions based on cellulosic polymers and lactose |
Country Status (7)
Country | Link |
---|---|
US (1) | US5389129A (en) |
EP (1) | EP0551700B2 (en) |
CN (1) | CN1065263C (en) |
DE (1) | DE69219303T3 (en) |
ES (1) | ES2100279T5 (en) |
GB (1) | GB2256648B (en) |
ZA (1) | ZA93225B (en) |
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-
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- 1991-05-29 GB GB9111514A patent/GB2256648B/en not_active Expired - Lifetime
-
1992
- 1992-01-17 DE DE69219303T patent/DE69219303T3/en not_active Expired - Lifetime
- 1992-01-17 EP EP92300406A patent/EP0551700B2/en not_active Expired - Lifetime
- 1992-01-17 ES ES92300406T patent/ES2100279T5/en not_active Expired - Lifetime
- 1992-05-28 US US07/889,775 patent/US5389129A/en not_active Expired - Lifetime
-
1993
- 1993-01-13 ZA ZA93225A patent/ZA93225B/en unknown
- 1993-01-16 CN CN93100417A patent/CN1065263C/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
US5389129A (en) | 1995-02-14 |
ZA93225B (en) | 1993-08-27 |
ES2100279T5 (en) | 2007-11-01 |
GB2256648A (en) | 1992-12-16 |
EP0551700B1 (en) | 1997-04-23 |
DE69219303D1 (en) | 1997-05-28 |
EP0551700A1 (en) | 1993-07-21 |
DE69219303T2 (en) | 1997-10-30 |
IE930025A1 (en) | 1993-07-28 |
CN1074920A (en) | 1993-08-04 |
GB2256648B (en) | 1995-08-30 |
DE69219303T3 (en) | 2007-10-11 |
ES2100279T3 (en) | 1997-06-16 |
CN1065263C (en) | 2001-05-02 |
GB9111514D0 (en) | 1991-07-17 |
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